Index of drugs

Induction and maintenance of general anesthesia. Sedation of artificially ventilated patients residing in an intensive care unit. Propofol 1%: sedation before diagnostic and surgical procedures as a single drug or in combination with local or regional anesthetic agents.

1 ml of emulsion contains 10 mg or 20 mg propofol. The product contains soybean oil.

A short-acting intravenous anesthetic. Within 30-40 s after the administration causes sleep (loss of consciousness); wake up after a single dose - after 4-6 min. It is 98% bound to plasma proteins. Pharmacokinetics in three stages - fast distribution (α phase) o T_0,5 about 2-4 min, elimination from T_0,5 30-60 min (β-phase) and redistribution of propofol from poorly supplied blood vessels. The drug is metabolized mainly in the liver to inactive metabolites. 88% of the dose is excreted in the urine.

Hypersensitivity to propofol or any of the excipients. Allergic to soybeans or peanuts. Sedation of children under 16 years.

It should not be used in patients with advanced cardiac insufficiency or other severe myocardial diseases, if necessary, extreme caution and careful monitoring of the patient. In patients with impaired cardiac, respiratory, renal or hepatic function, as well as elderly, debilitated, hypovolaemic, epilepsy or consciousness disorders, the preparation should be administered with particular caution and at a slower rate. Before administration of the preparation, disturbances such as heart failure, circulatory or respiratory failure and hypovolemia should be corrected. Due to the risk of vagotonia (cases of bradycardia as well as asystole) before induction or maintenance of anesthesia, intravenous anticholinergic drug should be considered, especially in situations when there is a high risk of vagotonia or when propofol is co-administered with other drugs that may cause bradycardia . The use of electroconvulsive therapy is not recommended. Special care should be taken in patients with fat metabolism disturbances and conditions in which lipid emulsions should be used with particular caution. In patients with a significant overweight, there is a greater risk of hemodynamic disturbances. Special care should be taken in patients with increased intracranial pressure and low mean blood pressure due to the risk of reducing the brain perfusion pressure. Do not use dilutions with Lidocaine solution in patients with hereditary acute porphyria. It is not recommended to use the drug in children under 1 month of age. The safety of propofol for sedation in children under 16 years has not been established. In children over 1 month up to 3 years should use a 1% propofol emulsion, special care should be taken with the preparation in this age group. Do not use propofol for sedation in patients under 16 years of intensive care or during diagnostic or surgical procedures. The formulation is based on soybean oil that can cause allergic reactions.

It should not be used during pregnancy unless clearly necessary. Propofol crosses the placenta and can inhibit vital signs in the newborn. Large doses of propofol (above 2.5 mg / kg to induce anesthesia and 6 mg / kg to maintain anesthesia) should be avoided. Propofol in small amounts is excreted in breast milk - women should stop breastfeeding 24 hours after administration of the drug.

Very common: pain at the injection site during the first injection of the drug (can be minimized by the simultaneous administration of lidocaine and the use of larger forearm veins and elbow flexion). Common: involuntary movements, myoclonus, slight arousal during induction of anesthesia, also during induction of anesthesia: hypotension, bradycardia, tachycardia (acceleration of heart rate), feeling hot, hyperventilation (acceleration of breath), transient apnea, cough, hiccups.Uncommon: significant hypotension (it may be necessary to reduce the rate of drug delivery and / or administration of vascular bed filling and vasoconstrictive drugs), markedly reduced blood pressure in patients with impaired perfusion of the myocardium or brain or in patients with hypovolaemia. During general anesthesia, bradycardia to asystole may increase (intravenous anticholinergic drug should be considered prior to induction or while maintaining anesthesia), cough should be maintained during anesthesia. Rare: thrombosis and phlebitis, epileptiform movements, including convulsions and spasm of the neck and back muscles, in the phase of regression of anesthesia: arrhythmia, cough, nausea or vomiting, headache and dizziness, chills and a feeling of cold, euphoria and sexual arousal; In addition, there may be: cases of postoperative fever, anaphylaxis (including Quincke's edema, bronchospasm, erythema and hypotension); after prolonged administration of propofol, cases of discoloration of the urine are observed. Very rare: delayed epileptic seizures (delay from several hours to several days), convulsions in patients with epilepsy, cases of postoperative loss of consciousness, pulmonary edema; pancreatitis has been reported (causative relationship has not been established); after accidental administration, it may lead to severe local tissue damage. There have been reports of isolated cases of serious adverse reactions occurring as a set of the following symptoms: rhabdomyolysis, metabolic acidosis, hyperkalemia and heart failure, sometimes fatal. The majority of these cases were observed in intensive care patients with propofol at a dose greater than 4 mg / kg / h. After administration of propofol with Lidocaine, dizziness, vomiting, drowsiness, seizures, bradycardia, arrhythmia, shock may rarely occur.

Intravenously. Only in a hospital setting or in properly equipped day wards, by doctors trained in anesthesia or patient care in an intensive care unit. The circulatory and respiratory capacity (eg ECG, pulse oximetry) should be constantly monitored. The dose should be selected individually depending on the patient's response and the premedication used. Usually, in addition to propofol, additional painkillers are required.
General anesthesia. Adults. Induction of anesthesia: gradually about 20-40 mg of propofol every 10 seconds, observing the patient's reaction, to clinical symptoms indicating the beginning of anesthesia. The majority of adults under 55 years of age need propofol at a dose of 1.5-2.5 mg / kg. In patients over 55 years of age and in patients classified as III and IV risk groups for ASA anesthesia, especially with impaired cardiac function, the dose should usually be reduced - the total dose can be reduced to a minimum of 1 mg / kg. It should also reduce the rate of administration of 20 mg every 10 seconds. Maintenance of anesthesia: infused continuously, Propofol 1% can also be given as further injections (bolus). A dose of 4-12 mg / kg should be administered. In the case of less aggravating surgical procedures (eg minimally invasive), a dose of approx. 4 mg / kg may be sufficient. In elderly patients, patients in a non-stabilized state, patients with impaired cardiac function or hypovolaemia, and patients classified to group III or IV risk of ASA anesthesia may need to reduce the dose. Only Propofol 1% - in order to maintain anesthesia by repeated injections (boluses), the Next dose of propofol should be increased by 25-50 mg depending on the patient's needs. In elderly people, do not use short-term injections (bolus, single or multiple), because it can cause cardiorespiratory failure.Children. In children over 1 month up to 3 years only use Propofol 1%. Induction of anesthesia: slow administration is recommended until signs and symptoms of anesthesia start to appear. The dose should be adjusted taking into account age and / or body weight. In children over 8 years of age, approximately 2.5 mg / kg are used, in children under 8 years, higher doses may be necessary. The initial dose should be 3 mg / kg. If necessary, additional doses may be given, with each subsequent dose being 1 mg / kg. bigger than the previous one.In young patients in the high-risk group (III or IV ASA risk group), a dose reduction is recommended. Maintenance of anesthesia: continuous infusion, 9-15 mg / kg / h. For children under 3 years, higher doses may be required than the recommended dosage range for older children. There are no data on maintaining anesthesia in children with repeated injections. Do not prolong the use of the drug beyond the maximum time, which is about 60 minutes, except in cases where there are clear indications (eg, malignant hyperthermia, in which the administration of volatile anesthetics should be strictly avoided). Administration of propofol with TCI is not recommended for induction or maintenance of general anesthesia in children.Sedation. Adults. Sedation during intensive care: for sedation in mechanically ventilated patients, continuous infusion is recommended. The dose should be adjusted according to the desired depth of sedation. Typically, a satisfactory degree of sedation is achieved at a delivery rate of 0.3-4 mg / kg / h. It is not recommended to infuse at a rate of more than 4 mg / kg / h. In order to achieve sedation in an intensive care unit, drug administration with TCI is not recommended. Sedation for diagnostic and surgical procedures - only Propofol 1%: in order to induce sedation the dose and speed of administration should be adjusted depending on clinical symptoms in the patient. For most patients, 0.5-1 mg / kg will be required. for 1-5 min to induce sedation. The sedation can be maintained by adjusting the infusion of the drug to the desired degree of sedation. The majority of patients will need 1.5- 4.5 mg / kg / h. The infusion can be supplemented by administering a short bolus of 10-20 mg if rapid sedation is needed. In patients over 55 years of age and in patients who are classified to ASA risk groups III or IV, it may be necessary to reduce the doses and the rate of administration.
Propofol 1% can be used for infusion in undiluted form or after dilution with 5% Glucose solution or 0.9% NaCl solution - in glass infusion bottles. Propofol 2% can only be administered in undiluted form in a continuous infusion, it should not be used in short injections (bolus) to maintain anesthesia. Observe the aseptic rules when taking the emulsion and throughout the infusion. Other medications or fluids co-administered with an infusion line through which propofol is administered should be administered near the cannula site using the Y-connector or three-way valve. Propofol must not be mixed with other solutions for injection or infusion; however, it can be administered via appropriate attachments at the cannula site - 5% glucose solution, 0.9% NaCl solution or 0.18% NaCl solution with 4% glucose. Propofol should not be administered through a microbiological filter.
The infusion of an undiluted preparation by one infusion system can not last longer than 12 hours (the infusion system and the reservoir should be discarded or replaced). Infusion of diluted Propofol 1%: maximum dilutions must not be greater than 1 part of the drug in 4 parts of 5% glucose solution (m / v) or 0.9% NaCl solution (m / v) (minimum concentration 2 mg / ml). The diluted drug should be prepared aseptically (subject to controlled and validated conditions) immediately prior to administration and should be administered within 6 hours of preparation. To reduce pain at the injection site, immediately before administration of the drug (1% and 2%), lidocaine may be injected. Propofol 1% just before administration can be mixed with a preservative-free lidocaine solution for injection (20 parts of the drug and at most 1 part of a 1% solution of lidocaine). These drugs should be mixed under controlled and validated aseptic conditions, and the mixture prepared in this way should be administered within 6 hours. Atracurium attractive muscle relaxants or mivacurium should be administered only after prior flushing of the infusion site through which propofol was administered.
The drug must not be administered for more than 7 days.